AXS-02

CHRONIC LOW BACK PAIN (CLBP) Associated with Modic Changes (MCs)

Chronic Low Back Pain (CLBP) Associated with Modic Changes (MCs)

CLBP is defined as persistent or fluctuating low back pain lasting at least three months. It is a disabling and costly condition that is associated with increased healthcare utilization.

The economic costs of CLBP are estimated to range from $12.2 billion to $90.6 billion annually in the United States. Factors that contribute to this economic impact include prolonged loss of function, consequent loss of work productivity, treatment costs, and disability payments.

Some patients with CLBP exhibit MCs. MCs are vertebral bone marrow changes that are visible on MRI of the spine, and that are associated with low back pain, based on published studies. Findings from various studies have demonstrated that the presence of MCs, especially type 1 MCs, is correlated with low back pain, predicts persistent symptoms, and sick leaves, and is associated with poor outcomes. These findings suggest that MCs are a potential target for pharmaceutical intervention.

AXS-02

AXS‑02 (disodium zoledronate tetrahydrate), is a potentially first‑in‑class, oral, targeted, non‑opioid therapeutic for chronic pain. We are initially developing AXS‑02 for the treatment of pain in the following two conditions: knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) and chronic low back pain (CLBP) associated with Modic changes (MCs). AXS-02 has been granted Fast Track designation by the FDA for the treatment of knee OA associated with BMLs. AXS-02 is an investigational product candidate not approved by the FDA.